Service-Only Providers and ISO 13485

Service-only providers gain ISO 13485:2016 certificate for their part of the process. It means that some requirements from clause 7.5 won't be applicable. For example, 7.5.2 Cleanliness of product, 7.5.3 Installation activities (if your service does not cover this), 7.5.5 Particular requirements for sterile medical devices, 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems, 7.5.9.2 Particular requirements for implantable medical devices. For other clauses, you will just replace the word production with service. For example, clause 7.5.1 Control of production and service provision in your system will be 7.5.1 Control of service provision; clause 7.5.6 Validation of processes for production and service provision in your system will be 7.5.6 Validation of processes for service provision.

According to the ISO 13485:2016, section 3 Terms and definitions, in point 3.15 is defined that there are four generic product categories and one of it is service. Service is the result of at least one activity necessarily performed at the interface between the supplier and customer and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangible product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a tax return);  the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of ambiance for the customer (e.g. in hotels and restaurants).

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